Expiration dating of repackaged medications

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This chapter is intended to provide guidance to those engaged in repackaging of drug products in accordance with 21 CFR 10.90.

A pharmacist who repackages under the state law needs to apply (1) the principal information provided in the USP general information chapter This chapter provides information to any person who removes drugs from their original manufacturer's container and repacks them into a different containerclosure system for resale or for distribution to hospitals or other pharmacies.

So, in this case it's 6 months = 9/13The law is on the FDA website: (Copy and paste) Manuals/Compliance Policy Guidance Manual/ucm074409Typically, the date you would put is one year from the day you pack that drug.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.'' The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose.

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(4) Repackaging and storage occur in an environment that is consistent with the conditions described in the original drug product's labeling.

If temperature and humidity are not specified in the original labeling, the product should be maintained at 'controlled room temperature' and in a 'dry place' (as defined in USP ) during the repackaging process, including storage.